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NCT Number: NCT07738718

Virtual Reality Distraction During Restorative Dental Treatment

This split-mouth randomized clinical trial will evaluate the effect of virtual reality (VR) distraction on pain perception, anxiety, physiological responses, and patient experience during local anaesthesia administration and restorative dental treatment in adults. Participants requiring bilateral Class I restorative treatment will receive treatment with and without VR distraction in randomized order. Pain, anxiety, heart rate, oxygen saturation, and patient-reported experience will be compared between the two conditions to determine whether VR improves patient comfort during routine dental care.

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Key information

Conditions

Dental Anxiety Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Professor Muhammad Zubair Ahmad

Ar Rass, Al-Qassim Region, 58883, Saudi Arabia

Location status: Recruiting

Location contact

Muhammad Zubair Ahmad, BDS,FCPS,MSc(OXON)EBHC,CHPE

CONTACT

[email protected]

+966163011111 ext. 10685

About this study

Dental anxiety and pain associated with local anesthesia and restorative procedures remain important barriers to seeking dental care and may negatively affect the overall patient experience. Virtual reality (VR) distraction has emerged as a non-pharmacological intervention that provides immersive audiovisual stimulation and may reduce procedural anxiety and pain by diverting patients' attention from the dental procedure.

This study is designed as a split-mouth randomized clinical trial in adult patients requiring bilateral Class I restorative treatment. Each participant will receive restorative treatment under two conditions: conventional treatment without VR and treatment with VR distraction, with the order of interventions randomized. The split-mouth design allows each participant to serve as their own control, minimizing inter-individual variability.

The primary objectives are to evaluate the effect of VR distraction on anxiety and pain perception during local anesthesia administration and restorative dental treatment. Secondary objectives include assessment of physiological responses (pulse rate, systolic and diastolic blood pressure, and oxygen saturation), patient comfort, unpleasant symptoms, treatment experience, awareness of the clinical surroundings, preference for future VR use, and the influence of VR on dental clinic selection.

The findings will contribute to the evidence regarding the effectiveness of immersive VR as an adjunctive, non-pharmacological approach for improving patient experience during routine restorative dental procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years) requiring bilateral Class I restorative dental treatment.
  • Presence of bilateral Class I carious lesions extending to the inner one-third of dentin (D3) with symptoms of reversible pulpitis.
  • Willing and able to provide written informed consent.
  • Willing to participate in the study and comply with study procedures.

Exclusion criteria

  • Children (<18 years).
  • American Society of Anesthesiologists (ASA) Physical Status Class III or higher.
  • Deep Class I carious lesions with pulpal involvement.
  • Mentally or medically compromised patients.
  • Patients presenting with acute dental pain, such as acute pulpitis.

Treatment and study plan

Virtual Reality Headset

Device

Participants will wear an immersive virtual reality headset during local anesthesia administration and restorative dental treatment. The virtual reality intervention is used as a non-pharmacological distraction technique to reduce pain perception and anxiety and to improve the overall patient experience during dental treatment.

Standard Dental Treatment

Other

Participants will receive conventional local anesthesia and restorative dental treatment without virtual reality distraction. All clinical procedures will be performed according to the standard treatment protocol and will serve as the control condition for comparison with the virtual reality intervention.

Primary outcomes

  1. Dental Anxiety

    Time frame: Baseline (pre-procedure) and immediately after each treatment session (post-procedure) on Day 1.

    Dental anxiety will be assessed using the 5-item Modified Dental Anxiety Scale (MDAS). Each item is scored from 1 (not anxious) to 5 (extremely anxious), with a total score range of 5-25; higher scores indicate greater anxiety.

  2. Pain Perception

    Time frame: Immediately after local anaesthesia administration during each treatment session on day 1.

    Pain intensity will be measured using a 0-10 cm Visual Analog Scale (VAS) following local anaesthesia administration and will be compared between the virtual reality and conventional treatment conditions. Higher scores indicate more pain.

Secondary outcomes

  1. Pulse rate

    Time frame: Before the dental procedure, immediately after local anaesthesia administration, and immediately after completion of the dental procedure on Day 1.

    Pulse rate (beats per minute) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.

  2. Systolic blood pressure

    Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.

    Systolic blood pressure (mmHg) will be recorded during dental treatment under virtual reality distraction and conventional treatment.

  3. Diastolic blood pressure

    Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.

    Diastolic blood pressure (mmHg) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.

  4. Oxygen saturation

    Time frame: Before the dental procedure, immediately after local anesthesia administration, and immediately after completion of the dental procedure on Day 1.

    Peripheral oxygen saturation (SpO₂, %) will be recorded during dental treatment under virtual-reality distraction and during conventional treatment.

  5. Patient comfort

    Time frame: Immediately after completion of each treatment session (Day 1).

    Patient-reported comfort following dental treatment with virtual reality distraction and following conventional treatment, assessed using a structured post-treatment questionnaire.

  6. Unpleasant symptoms

    Time frame: Immediately after completion of each treatment session (Day 1).

    Patient-reported unpleasant symptoms experienced following dental treatment with virtual reality distraction and following conventional treatment, assessed using a structured post-treatment questionnaire.

  7. Perceived improvement in treatment experience

    Time frame: Immediately after completion of each treatment session (Day 1).

    Patient-reported perception of the overall dental treatment experience following virtual reality distraction versus conventional treatment, assessed using a structured post-treatment questionnaire.

  8. Preference for virtual reality in future dental treatment

    Time frame: Immediately after completion of both treatment sessions (Day 1).

    Patient preference for using virtual reality during future dental treatment, assessed after experiencing both virtual reality distraction and conventional treatment using a structured post-treatment questionnaire.

  9. Influence of virtual reality on dental clinic selection

    Time frame: Immediately after completion of both treatment sessions (Day 1).

    Patient-reported willingness to choose a dental clinic offering virtual reality after experiencing both virtual reality distraction and conventional treatment, assessed using a structured post-treatment questionnaire.

  10. Awareness of the clinical surroundings

    Time frame: Immediately after completion of each treatment session (Day 1).

    Patient awareness of the clinical surroundings during dental treatment under virtual reality distraction and conventional treatment, assessed using a structured post-treatment questionnaire.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Registry information

Official study title

The Impact of Virtual Reality on Pain Perception and Patients' Experience Following the Administration of Local Anesthesia and Restorative Dental Treatment: Split-Mouth Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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